NCT04897594

Brief Summary

This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2021

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2022

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 7, 2024

Completed
Last Updated

June 7, 2024

Status Verified

December 1, 2023

Enrollment Period

1.3 years

First QC Date

May 18, 2021

Results QC Date

December 21, 2023

Last Update Submit

December 21, 2023

Conditions

NASH - Nonalcoholic Steatohepatitis

Keywords

Vascular adhesion protein-1(VAP-1)/ semicarbazide-sensitive amine oxidase (SSAO)Nonalcoholic steatohepatitis (NASH)Nonalcoholic Fatty Liver Disease (NAFLD)

Outcome Measures

Primary Outcomes (2)

  • Patient Incidence of Adverse Events for TERN-201 Versus Placebo

    Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.

    Day 1 through Week 16

  • Treatment-Emergent Laboratory Abnormalities

    Number of patients with any worsening of ≥ 2 NCI CTCAE Grades in each laboratory assessment category. CTCAE = Common Terminology Criteria for Adverse Events; NCI = National Cancer Institute; laboratory abnormalities were classified according to NCI CTCAE, version 5, Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-Threatening

    Day 1 through Week 16

Study Arms (3)

TERN-201 10mg

EXPERIMENTAL

Orally administered

Drug: TERN-201

TERN-201 20mg

EXPERIMENTAL

Orally Administered

Drug: TERN-201

Placebo

PLACEBO COMPARATOR

Orally administered

Other: Placebo

Interventions

TERN-201DRUG

Investigational drug

TERN-201 10mgTERN-201 20mg
PlaceboOTHER

Matching placebo

Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 to 75 years of age
  • Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2
  • Presumed NASH based on clinical characteristics or prior liver biopsy
  • ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women
  • MRI-cT1 value\> 800 ms
  • Written informed consent

You may not qualify if:

  • History or clinical evidence of chronic liver diseases other than NAFLD
  • History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment
  • History of liver transplant, or current placement on a liver transplant list
  • Weight loss of \> 5% total body weight within 3 months prior to Screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Terns Clinical Study Site 1018

Tucson, Arizona, 85712, United States

Location

Terns Clinical Study Site 1024

Tucson, Arizona, 85712, United States

Location

Terns Clinical Study Site 1004

Coronado, California, 92117, United States

Location

Terns Clinical Study Site 1039

Los Angeles, California, 90048, United States

Location

Terns Clinical Study Site 1001

Panorama City, California, 91402, United States

Location

Terns Clinical Study Site 1040

Rialto, California, 92377, United States

Location

Terns Clinical Study Site 1013

San Diego, California, 92093, United States

Location

Terns Clinical Study Site 1010

Bastrop, Louisiana, 71220, United States

Location

Terns Clinical Study Site 1006

San Antonio, Texas, 78215, United States

Location

Terns Clinical Study Site 1003

San Antonio, Texas, 78229, United States

Location

Terns Clinical Study Site 1019

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Study Director
Organization
Terns, Inc.
clinicaltrials@ternspharma.com
+1 650-525-5535

Study Officials

  • clinicaltrials@ternspharma.com

    Terns, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Triple
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2021

First Posted

May 21, 2021

Study Start

May 20, 2021

Primary Completion

September 2, 2022

Study Completion

September 2, 2022

Last Updated

June 7, 2024

Results First Posted

June 7, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

US(11)